Depression
Conditions
Brief summary
In a sample of patients already receiving esketamine treatment as part of their clinical care, this project seeks to test whether we can improve depression by introducing helpful information delivered by a computer-based training protocol. This work could ultimately lead to the ability to treat depression more efficiently and with broader dissemination by rapidly priming the brain for helpful forms of learning.
Interventions
BEHAVIORALCognitive Training
8 sessions of web-based cognitive training
BEHAVIORALSham Training
8 sessions of web-based sham training
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Any patient aged 18-80 in the esketamine clinic in the Center for Interventional Psychiatry. The clinic's extensive screening and eligibility criteria for esketamine treatment will not be altered in any way, other than imposing the study-specific age range and the two
Exclusion criteria
below.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery Asberg Depression Rating Scale | Trajectories from baseline through 1 month | depression severity; range 0-60; high score=worse outcome |
| Quick Inventory of Depressive Symptoms | Trajectories from baseline through 1 month | Self-reported depression (range: 0-27; higher scores = worse outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression Scale--Improvement | Trajectories from baseline through 1 month | range 1-7 (higher score=worse outcome) |
| Hamilton Depression Rating Scale modified score | Trajectories from baseline through 1 month | Clinician-rated depression (range: 0-52; higher scores = worse outcome) |
| Clinical Global Impression Scale--Severity | Trajectories from baseline through 1 month | range 1-7 (higher score=worse outcome) |
| Frequency of scheduled esketamine visits | During first month | The frequency of scheduled esketamine visits, optimized according to clinicians' judgment of response and patient preferences |
| Number of patients terminated from esketamine therapy | During first 6 months | Number with esketamine treatment terminated by the clinic's embedded providers due to lack of clinical response after 1-month of treatment |
Other
| Measure | Time frame | Description |
|---|---|---|
| Ease of use | Assessment at 'post-CT' timepoint (completed approximately 1 week following randomization) | self-report slider scale rating; range = 0-100; high score=better rating |
| Satisfaction with Cognitive Training | Assessment at 'post-CT' timepoint (completed approximately 1 week following randomization) | self-report slider scale rating; range = 0-100; high score=better rating |
| Future likelihood of using Cognitive Training | Assessment at 'post-CT' timepoint (completed approximately 1 week following randomization) | self-report slider scale rating; range = 0-100; high score=better rating |
| Helpfulness | Assessment at 'post-CT' timepoint (completed approximately 1 week following randomization) | self-report slider scale rating; range = 0-100; high score=better rating |
| Client Satisfaction Questionnaire | Assessment at 'post-CT' timepoint (completed approximately 1 week following randomization) | self-reported satisfaction with treatment; range 8-32; higher score=better rating |
Countries
United States
Outcome results
None listed